Medical DeviceView official recall notice →
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D;
Brand / Firm
Product
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.
Reason for recall
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Units affected
2262 kits
Description
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.